Medscape Medical News - News Alerts

• FDA Tweaks Impella Indications on Basis of Post-Approval Study The updated indication tightens the description of eligible patients on the basis of post-approval study results but in line with premarket study entry criteria.
  Medscape Medical News, December 05, 2022
• Alert Atezolizumab Bladder Cancer Indication Withdrawn in US The manufacturer has voluntarily withdrawn the US indication that covered its use in certain patients with bladder and urinary tract cancers.
  Medscape Medical News, November 29, 2022
• Alert FDA Rejects Poziotinib for Certain Types of NSCLC The drug was not approved for the treatment of patients with previously treated locally advanced or metastatic nonsmall cell lung cancer harboring HER2 exon 20 insertion mutations.
  Medscape Medical News, November 25, 2022
• Alert FDA Alert: 'Substantial' Hypocalcemia Risk with Prolia Use The US Food and Drug Administration sent an alert today that it's investigating an apparent link between the use of denosumab (Prolia) by patients on dialysis and serious hypocalcemia outcomes.
  Medscape Medical News, November 22, 2022
• Alert Class I Recall of LifeSPARC Advanced Circulatory Support System A software malfunction may cause the system's controller to wrongly enter critical failure mode causing the pump to stop working; 66 complaints and 2 injuries have been reported.
  Medscape Medical News, September 30, 2022
• Alert NY Gov Declares State Disaster Emergency Over Polio Polio virus has been detected in wastewater samples in New York City and in four New York counties: Rockland, Orange, Sullivan, and Nassau.
  Medscape Medical News, September 09, 2022
• Alert FDA Warns of Clip Lock Malfunctions With MitraClip Devices Letters sent today by the FDA and Abbott Vascular, the device manufacturer, warn about an increase in reports that the device's clip lock can malfunction.
  Medscape Medical News, September 08, 2022
• Alert FDA Warns of Cancer Risk in Scar Tissue Around Breast Implants The warning comes after reports of patients with squamous cell carcinoma or various lymphomas around breast implant scar tissue, but the risk remains rare.
  Medscape Medical News, September 08, 2022
• Alert More Lots of Diabetes Pill Metformin Recalled in US A further 33 lots of extended-release metformin 750 mg tablets have been voluntarily recalled in the US, by Viona, due to possible contamination with a cancer-causing chemical.
  Medscape Medical News, December 30, 2021